The constant evolution of legislative, regulatory and marketplace demands on the life sciences industry requires experienced counsel to navigate the complex array of regulations and policies enforced by the U.S. Food and Drug Administration (FDA). At Akin Gump Strauss Hauer & Feld LLP, we take a strategic, life-cycle approach to counseling clients in the medical device, pharmaceutical, biotechnology, health care technology and food/dietary supplement industries. From capitalization through postmarket representation, health care policy and legislative strategy, our experienced lawyers and advisors work with clients to ensure that they are compliant, but also that their global regulatory strategies and legislative interests are aligned to maximize opportunities for coverage and reimbursement, entry into new markets and further research and development. We advise clients in anticipating, adapting to, and profiting from upcoming changes in the business landscape.
Akin Gump’s food and drug law practice works in conjunction with other firm practices to offer clients comprehensive, regulatory, enforcement, policy and strategic counsel. Our attorneys and advisors have ample experience with all of the industries that fall under the jurisdiction of the FDA and its analogous organizations worldwide. Our experience includes:
- Regulatory Navigation. Akin Gump attorneys counsel companies and investors concerning the probable FDA regulatory status and approval pathway of proposed new products and concepts. We offer our clients sketch-to-product counsel, including navigating FDA’s premarket clearance process; determining the application type and regulatory pathway and assisting with supporting data required for approval; drafting meeting requests and preparing for meetings with FDA and expert committees, as well as counterparts in key international markets; assisting with the preparation of requests for determinations for combination products; resolving complications that may arise during FDA application review; providing guidance throughout the approval process; analyzing the nature of applications and the applicability of FDA “exclusivity” and patent provisions; and reviewing promotional statements and claims to promote products in the market.
- Biotechnology. Our team has extensive experience representing companies whose products use recombinant DNA, monoclonal antibodies and other biotechnology; counseling biotech clients with respect to the Orphan Drug Act, the federal multiagency biotech regulatory regime and the judiciary’s role in protecting both the biotech industry and public from administrative abuses; and assisting companies in addressing biotech-related trade problems for food and agricultural products.
- Product Development. We represent clients before the FDA, U.S. Department of Agriculture (USDA) and the U.S. Patent and Trademark Office (USPTO) in all phases of the product development cycle. We provide guidance on product and ingredient notifications, bioresearch and FDA inspections, regulatory and due diligence audits and Good Manufacturing Practice and Quality Systems Regulation requirements. Our attorneys also advise on minimizing FDA regulatory costs, licensing agreements, manufacturer and distributor registration, pending legislation, product corrective actions and regulatory aspects of product development.
- Policy and Legislation. Our FDA team has a clear, detailed understanding of legislative and regulatory reform efforts and the potential impact, benefits and risk associated with each of our clients’ initiatives. Our food and drug law practice, in conjunction with our exceptional public law and policy and international trade practices, offers insightful, actionable counsel regarding the workings of Congress and the executive branch, as well as the European Union (EU) and other regulatory systems, to facilitate proactive client strategies. We represent client interests in the legislative and regulatory process and work with foreign governments throughout the world on questions of regulations and legislation.
- Food Safety. Akin Gump lawyers, serving as counselors, advocates and advisors in state, federal and international fora, help clients facing issues such as consumer allergies, approval for new food ingredients and food contact substances, product chain accountability, divergent national safety standards and new legal and regulatory perspectives on existing ingredients. We also counsel clients concerning contaminated food claims and related challenges, including dealing with regulatory authorities, the media and customers and defending product liability actions.
- Labeling, Packaging and Recalls. We help clients ensure compliance with state and federal regulations by advising and reviewing labeling and packaging, including food labeling issues. When a recall is required, we assist clients in all stages, from regulator notification to media damage containment and reputation recovery. In addition to crafting legal notices, our lawyers—in collaboration with public relations advisors—work with regulatory agencies, insurance carriers, distributors and customers to help clients develop and implement a media relations strategy.
- Imports/Exports. We collaborate closely with our international trade practice to help clients deal successfully with international trade regulation and policy issues. Our credibility and reputation with the Office of the U.S. Trade Representative (USTR); the International Trade Commission (ITC); the State, Treasury, Commerce and Justice departments; and CBP, are key to our ability to help clients achieve their international trade objectives. Our attorneys prepare and review international sales agreements, foreign-source production agreements and agent and distributor agreements. We advise on U.S. export control and antiboycott laws, international competition policy, export finance, international payment procedures, foreign exchange matters, global customs laws and procedures and international transportation, as well as on classification and valuation of imports and entry procedures. We also represent clients in ITC proceedings under antidumping and countervailing duty laws and related measures for redressing unfair trade practices or providing assistance to U.S. industries injured by imports.
- Routine and Special Inspections. Our team is familiar with the relevant best practices and assists clients through the complicated legal and regulatory aspects of routine or special inspections.
- Enforcement Proceedings. Akin Gump offers the complete range of legal advice, from the establishment and maintenance of compliance programs to representation before U.S. Attorneys’ offices, the U.S. Department of Justice and FDA enforcement proceedings. We represent clients in matters ranging from warning letters to defense of companies and individuals facing criminal prosecution.